30 January 2015 - Zogenix, Inc., a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration(FDA) has approved a new formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek. BeadTek is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended. Concurrently, Zogenix has ongoing Human Abuse Liability studies, which will further characterize the abuse-deterrent properties of the new formulation. Zogenix intends to submit these data in the second half of 2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

BeadTek incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents. Zohydro ER is the only long-acting hydrocodone product administered every 12 hours, and the new formulation maintains the same efficacy and pharmacokinetic profile of the original formulation. Transition to Zohydro ER with BeadTek is expected to occur in the second quarter of 2015 for all prescribed strengths ranging from 10 mg to 50 mg, without disruption to patients currently on therapy.

For more details, go to: http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-newsArticle&cat=news&id=2012326